Xcopri Titration Pack (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — NDC: 71699-999-99 — 12.5 mg 14-count and 25 mg 14-count Titration Pack Label (Back)

12.5 mg 14-count and 25 mg 14-count Titration Pack Label (Back)
(click image for full-size original)

XCOPRI TITRATION PACK cenobamate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71699-201
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71699-201-28 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 14 BLISTER PACK 14
Part 2 14 BLISTER PACK 14
Part 1 of 2
CENOBAMATE cenobamate tablet
Product Information
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENOBAMATE (CENOBAMATE) CENOBAMATE 12.5 mg
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code SK;12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839
Part 2 of 2
CENOBAMATE cenobamate tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENOBAMATE (CENOBAMATE) CENOBAMATE 25 mg
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 8mm
Flavor Imprint Code SK;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839 03/12/2020
XCOPRI cenobamate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71699-050
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENOBAMATE (CENOBAMATE) CENOBAMATE 50 mg
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SK;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71699-050-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:71699-050-99 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839 04/30/2021
XCOPRI TITRATION PACK cenobamate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71699-202
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71699-202-28 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 14 BLISTER PACK 14
Part 2 14 BLISTER PACK 14
Part 1 of 2
CENOBAMATE cenobamate tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENOBAMATE (CENOBAMATE) CENOBAMATE 50 mg
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SK;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839
Part 2 of 2
CENOBAMATE cenobamate tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENOBAMATE (CENOBAMATE) CENOBAMATE 100 mg
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SK;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839 03/12/2020
XCOPRI MAINTENANCE PACK cenobamate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71699-102
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71699-102-56 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 28 BLISTER PACK 28
Part 2 28 BLISTER PACK 28
Part 1 of 2
CENOBAMATE cenobamate tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENOBAMATE (CENOBAMATE) CENOBAMATE 50 mg
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SK;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839
Part 2 of 2
CENOBAMATE cenobamate tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENOBAMATE (CENOBAMATE) CENOBAMATE 200 mg
Product Characteristics
Color ORANGE (light orange) Score no score
Shape OVAL (modified oval) Size 19mm
Flavor Imprint Code SK;200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839 03/12/2020 10/31/2022
XCOPRI cenobamate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71699-100
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENOBAMATE (CENOBAMATE) CENOBAMATE 100 mg
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SK;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71699-100-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839 03/12/2020
XCOPRI cenobamate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71699-150
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENOBAMATE (CENOBAMATE) CENOBAMATE 150 mg
Product Characteristics
Color ORANGE (light orange) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code SK;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71699-150-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839 03/12/2020
XCOPRI TITRATION PACK cenobamate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71699-203
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71699-203-28 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 14 BLISTER PACK 14
Part 2 14 BLISTER PACK 14
Part 1 of 2
CENOBAMATE cenobamate tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENOBAMATE (CENOBAMATE) CENOBAMATE 150 mg
Product Characteristics
Color ORANGE (light orange) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code SK;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839
Part 2 of 2
CENOBAMATE cenobamate tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENOBAMATE (CENOBAMATE) CENOBAMATE 200 mg
Product Characteristics
Color ORANGE (light orange) Score no score
Shape OVAL (modified oval) Size 19mm
Flavor Imprint Code SK;200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839 03/12/2020
XCOPRI MAINTENANCE PACK cenobamate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71699-103
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71699-103-56 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 28 BLISTER PACK 28
Part 2 28 BLISTER PACK 28
Part 1 of 2
CENOBAMATE cenobamate tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENOBAMATE (CENOBAMATE) CENOBAMATE 150 mg
Product Characteristics
Color ORANGE (light orange) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code SK;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839
Part 2 of 2
CENOBAMATE cenobamate tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENOBAMATE (CENOBAMATE) CENOBAMATE 200 mg
Product Characteristics
Color ORANGE (light orange) Score no score
Shape OVAL (modified oval) Size 19mm
Flavor Imprint Code SK;200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839 03/12/2020
XCOPRI cenobamate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71699-200
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENOBAMATE (CENOBAMATE) CENOBAMATE 200 mg
Product Characteristics
Color ORANGE (light orange) Score no score
Shape OVAL (modified oval) Size 19mm
Flavor Imprint Code SK;200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71699-200-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839 03/12/2020
XCOPRI MAINTENANCE PACK cenobamate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71699-104
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71699-104-56 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 28 BLISTER PACK 28
Part 2 28 BLISTER PACK 28
Part 1 of 2
XCOPRI cenobamate tablet, film coated
Product Information
Item Code (Source) NDC:71699-100
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENOBAMATE (CENOBAMATE) CENOBAMATE 100 mg
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SK;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839
Part 2 of 2
XCOPRI cenobamate tablet, film coated
Product Information
Item Code (Source) NDC:71699-150
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENOBAMATE (CENOBAMATE) CENOBAMATE 150 mg
Product Characteristics
Color ORANGE (light orange) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code SK;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839 04/30/2021
XCOPRI TITRATION PACK cenobamate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71699-999
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71699-999-99 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 14 BLISTER PACK 14
Part 2 14 BLISTER PACK 14
Part 1 of 2
CENOBAMATE cenobamate tablet
Product Information
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENOBAMATE (CENOBAMATE) CENOBAMATE 12.5 mg
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code SK;12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839
Part 2 of 2
CENOBAMATE cenobamate tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENOBAMATE (CENOBAMATE) CENOBAMATE 25 mg
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 8mm
Flavor Imprint Code SK;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212839 03/12/2020
Labeler — SK Life Science, Inc. (001993265)

Revised: 12/2022 SK Life Science, Inc.

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